Cell Culture Technical Specialist - Upst

Pe Global

Dublin

PE Global are currently recruiting for a Technical Services Specialist - Downstream for a client site in Dublin- The Cell Culture (Upstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at client’s facility in, Dublin. The Technical Specialist will provide cell culture processing expertise to support the facility design, start-up and routine commercial manufacturing from vial thaw, through typical scale up processes, to seed and production bioreactors, with harvest and clarification technologies respectively. The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for cell culture unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability. Principal Responsibilities To provide process expertise in the area of buffer/media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup of client’s BDS facility in Dublin. Working knowledge of typical cell culture unit operations, cause and effect, product expression, in-process tests. To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents. To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies. To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements. To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines. To identify and implement process improvements; e.g. yield, cycle time reduction. To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale. May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution. To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution. Lead any key process changes using change control management system. Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits. Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations. To author and review IND, BLA and other technical documents for regulatory agency submissions. To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections. Skills: Minimum 5 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization. Technical and operational knowledge of multiple unit operations in cell culture processing. In-depth technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration. Strong understanding of technology transfer, scale-up process and cleaning validation. Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant. Experience of Validation / Verification of GMP equipment or processes would be beneficial. Experience of design, commissioning and start-up of a bulk drug substance facility would be beneficial. Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings. Ability to present and defend technical and scientific approaches in both written and verbal form. Ability to drive for results independently and adapt to rapidly changing priorities. Experience of authoring CMC sections of regulatory submissions would be advantageous. Experience of Technology Transfer activities is advantageous. Knowledge or experience of start-up or systems would be ideal. Detail orientated. Technical writing competency. Education: Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage. Interested Candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

2106 days ago